Preparing for USP 797 Enforcement: 30 Priorities in the Next 60 Days
Compounding expert, Eric S. Kastango, BS Pharm, MBA, FASHP, discusses the announcement from USP and recommends best practices to move forward.
On Monday, September 23, 2019, United States Pharamacopeia (USP) announced it is postponing enforcement of USP Chapters <795>, <797> and <825> originally scheduled for December 1, 2019 after receiving appeals on certain provisions. Additionally, it announced USP Chapter <800> is not subject to any pending appeals and will become official on December 1, 2019, however is considered informational and not compendially applicable during the postponement and pending resolutions of appeals of <795> and <797>.
Additionally, we discuss areas to prioritize and proactively address for USP 797 compliance.
The following topic areas are explored in addition to others:
-
Assigning Beyond-use Dates
-
The use of Master Formulation and Compounding Records
-
Best practices for Air & Surface Sampling
-
Establishing a Designated Person
-
Review of Engineering Controls
-
Requirements for Personal Hygiene & Garbing